This template package features a universal IQ/OQ Protocol template that provides a ready-to-populate document to generate an IQ, OQ, or IOQ in the pharma or biotech industry.
This template package features a comprehensive outline of the information required in a User Requirements Specification for the Biotechnology, Medical Device or Pharmaceutical industries. It includes sections for process overview, design and construction, operational requirements, automation requirements, safety, acceptance and delivery, and documentation. Suggested technical content is also included throughout the template.
Kymanox provides experienced personnel to perform data logging services using the Kaye Validator 2000 to deliver the information that you need.
This training package features a training presentation that provides an overview of validation and discusses the need for validation, the validation process, and what it means to operate in a state of control.
This training package features a training presentation which provides training and quality professionals with a strong tool for training their workforce in the basics of post validation monitoring and validation lifecycle management.
This template package features a universal Quality Plan template with example text that can be integrated into any documentation system and used to define the quality practices, resources, and activities relevant to a process.
This template package features a universal traceability matrix template that provides a ready-to-populate document and spreadsheet to generate a trace matrix for any system validation.